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Scale-up of a DPI carrier-based formulation and blending process optimization

by multivariate statistical analysis of a Design of Experiments

Authors:

Filipa Maia

Source:

RDD Europe 2017

Ddry powder carrier-based formulation of a model active pharmaceutical ingredient (API), which includes coarse and fine lactose grades, is in development.
The initial development work was conducted at a small scale low-shear mixer in order to demonstrate proof of concept. A scale-up of the blending process was necessary to support clinical trials.
This work focuses on the blending process scale-up and optimization, which was performed according to a design of experiments (DOE) approach considering the following variables: